BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 906
AUTHOR: Correa
AMENDED: April 7, 2014
HEARING DATE: April 30, 2014
CONSULTANT: Marchand
SUBJECT : Elective Percutaneous Coronary Intervention (PCI)
Offsite Program.
SUMMARY : Establishes the Elective Percutaneous Coronary
Intervention Offsite Program to allow the California Department
of Public Health to certify general acute care hospitals that
are licensed to provide cardiac catheterization laboratory
service in California, but are not licensed to perform onsite
cardiac surgery, to perform scheduled, elective percutaneous
transluminal coronary angioplasty and stent placement for
eligible patients.
Existing law:
1.Licenses and regulates general acute care hospitals by the
California Department of Public Health (CDPH), and in addition
to the basic services offered under that license, permits
general acute care hospitals to seek approval from CDPH to
offer special services, including cardiac surgery and cardiac
catheterization laboratory services.
2.Requires CDPH, for cardiac catheterization laboratory
services, to adopt standards and regulations that specify that
only diagnostic services, and which diagnostic services, may
be offered by an acute care hospital that is approved to
provide cardiac catheterization laboratory service but is not
also approved to provide cardiac surgery service.
3.Establishes the Elective Percutaneous Coronary Intervention
(PCI) Pilot Program to allow CDPH to authorize up to six
general acute care hospitals that are licensed to provide
cardiac catheterization laboratory service in California, and
that meet specified requirements, to perform scheduled,
elective percutaneous transluminal coronary angioplasty and
stent placement for eligible patients without onsite cardiac
surgery.
4.Establishes an advisory oversight committee, comprised of one
Continued---
SB 906 | Page 2
interventionalist from each pilot hospital, an equal number of
cardiologists from non-pilot hospitals, and a representative
from CDPH, to oversee, monitor, and make recommendations to
CDPH concerning the Elective PCI Pilot Program.
5.Requires the advisory oversight committee to submit at least
two reports to CDPH during the pilot period, and to conduct a
final report by November 30, 2013, including recommendations
for the continuation or termination of the pilot program.
6.Requires CDPH to prepare and submit a report to the
Legislature on the results of the Elective PCI Pilot Program
within 90 days of receiving the final report from the advisory
oversight committee. Requires this report to recommend whether
elective PCI without onsite cardiac surgery should be
continued in California, and if so, under what conditions.
7.Sunsets the provisions of law creating the Elective PCI Pilot
Program on January 1, 2015.
This bill:
1.Establishes the Elective Percutaneous Coronary Intervention
Offsite Program (Elective PCI Offsite Program) in CDPH to
allow CDPH to certify general acute care hospitals that are
licensed to provide cardiac catheterization laboratory service
in California, and that meet the requirements of this bill, to
perform scheduled, elective percutaneous transluminal coronary
angioplasty and stent placement for eligible patients.
2.Defines various terms for purposes of this bill, including
that "elective PCI" means scheduled percutaneous transluminal
coronary angioplasty and stent placement, and does not include
urgent or emergency PCI that is scheduled on an ad hoc basis,
and that "eligible hospital" means a general acute care
hospital that has a licensed cardiac catheterization
laboratory and is in substantial compliance with all
applicable state and federal licensing laws and regulations.
3.Requires an eligible hospital, as defined, in order to
participate in the Elective PCI Offsite Program, to obtain
certification from CDPH and to meet all of the following
requirements:
a. Demonstrate that it complies with the
recommendations of the Society for Cardiovascular
Angiography and Interventions, the American College of
SB 906 | Page
3
Cardiology Foundation, and the American Heart
Association, for performance of PCI without onsite
cardiac surgery, as those recommendations may evolve
over time;
b. Provide evidence showing the full support from
hospital administration in fulfilling the necessary
institutional requirements, including, but not limited
to, appropriate support services such as respiratory
care and blood banking; and,
c. Participate in, and provide timely submission
of data to, the American College of
Cardiology-National Cardiovascular Data Registry, and
confer rights to transfer this data to the Office of
Statewide Health Planning and Development (OSHPD).
4.Requires an eligible hospital to submit an application to CDPH
to obtain certification to participate in the Elective PCI
Offsite Program, and requires the application to include
sufficient information to demonstrate compliance with the
standards set forth in this bill, and to include other
specified information, including a description of backup
emergency services.
5.Permits an eligible hospital that was participating in the
Elective PCI Pilot Program to continue to perform elective PCI
and to be considered an offsite hospital provided that the
hospital obtains a certification under the provisions of this
bill by January 1, 2016.
6.Requires OSHPD, using data transferred from the American
College of Cardiology-National Cardiovascular Data Registry,
as specified under this bill, to annually develop and make
available to the public a report regarding each offsite
hospital's performance on mortality, a stroke rate, and an
emergency coronary artery bypass graft rate.
7.Permits CDPH to establish an advisory oversight committee
composed of two interventionalists from offsite hospitals, two
interventionalists from hospitals that are not offsite
hospitals, and a representative of CDPH, for the purpose of
analyzing the report issued by OSHPD and making
recommendations for changing the data to be included in future
reports issued by OSHPD.
8.Requires CDPH to revoke a certification issued under this bill
SB 906 | Page 4
if at any time an offsite hospital fails to meet the criteria
set forth in this bill. Permits an offsite hospital whose
certification is revoked to request an appeal, and specifies
that these hospitals are not precluded from reapplying for
certification.
9.Permits CDPH to charge offsite hospitals a supplemental
licensing fee, the amount of which cannot exceed the
reasonable cost to CDPH of overseeing the program.
10.Permits CDPH to contract with a professional entity with
medical program knowledge to meet the requirements of this
bill.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1.Author's statement. According to the author, PCI is the
treatment of choice for certain types of blocked heart
vessels. Until the passage of SB 891 (Correa), Chapter 295,
Statutes of 2008, only California hospitals that were licensed
to provide cardiac surgery, such as bypass surgery, were
permitted to perform scheduled, elective PCI treatment. SB 891
created the Elective PCI Pilot Program, which allowed six
California general acute care hospitals that are licensed to
provide cardiac catheterization services, that have off-site
cardiac surgery backup, and that met the specified rigorous
selection criteria, to perform scheduled, elective PCI for low
to medium risk patients. SB 891 required CDPH to prepare and
submit a report to the Legislature on the results of the
Elective PCI Pilot Program, including a recommendation on
whether elective PCI without onsite cardiac surgery should be
continued in California, and if so, under what conditions. SB
357 (Correa), Chapter 202, Statutes of 2013, enabled the pilot
hospitals to continue with the pilot program while CDPH
reviewed the data from the advisory committee and submitted
the report to the legislature. The author states that the
reports compiled by the advisory committee show the morbidity
and mortality results of procedures from the pilot hospitals
from the past two plus years have been consistent with the
morbidity and mortality results from hospitals not enrolled in
the pilot program. According to the author, this bill would
allow hospitals to perform PCI without onsite cardiac surgery.
PCI treatment would expand patients' access to care,
particularly benefiting underinsured and poor patients who are
SB 906 | Page
5
often least likely to undergo PCI due to barriers to accessing
specialized cardiac services such as geography, distance,
culture, race, language and poverty. For many patients,
diagnosis and treatment can be provided during one procedure -
reducing risk, the length of stay and the stress and anxiety
associated with undergoing medical treatment in another
community.
2.What is percutaneous transluminal coronary angioplasty?
According to Stanford Medical Center online health library,
percutaneous transluminal coronary angioplasty is performed to
open blocked coronary arteries cause by coronary artery
disease and to restore arterial blood flow to the heart tissue
without open-heart surgery. A special catheter with a tiny
balloon at its tip is inserted into the coronary artery to be
treated. The balloon is inflated once the catheter has been
placed into the narrowed area of the coronary artery. The
inflation of the balloon compresses the fatty tissue in the
artery and makes a larger opening inside the artery for
improved blood flow. Once the artery has been opened, a stent
is placed in the artery. A stent is a tiny, expandable metal
coil that is inserted into the newly opened area of the artery
to help keep the artery from narrowing or closing again.
3.PCI Pilot Program background. According to the Senate Health
Committee analysis of SB 891 (Correa), which created the PCI
Pilot Program, the legislation was prompted by studies showing
that elective PCI for low- to medium-risk patients can be
safely and effectively performed at hospitals without cardiac
surgery services if they meet certain requirements. The
current limitation on hospitals performing interventional
cardiac procedures, if they are not also licensed to perform
cardiac surgery, was enacted over 25 years ago. Since that
time, there have been great technological and methodological
advances in interventional cardiology that have significantly
improved patient outcomes and reduced incidents of emergency
cardiac surgery. At the time the PCI Pilot Program was
enacted, hospitals in 28 states were already performing
elective PCI without on-site surgical capability but with
transfer arrangements to facilities that do have such
capability. Today, 45 states permit elective PCI without
onsite surgery.
The six hospitals selected by DPH for the pilot program were:
Los Alamitos Medical Center; Sutter Roseville Medical Center;
SB 906 | Page 6
Kaiser Permanente Walnut Creek Medical Center; Doctors Medical
Center-San Pablo; Clovis Community Medical Center; and St.
Rose Hospital in Hayward.
The final report from the PCI Pilot Program Advisory Oversight
Committee, dated November 19, 2013, found no significant
outcome differences between the six hospitals in the pilot
program, and the control group of 116 hospitals performing
these procedures with onsite cardiac surgery services. No
strong relationship was noted between hospital volumes and
overall safety and efficacy. Potential worse outliers were
identified only in the non-pilot control group of hospitals
with onsite surgery.
4.Related legislation. SB 830 (Galgiani) requires OSHPD to
include "heart valve repair and replacement surgeries" in
their annual risk adjusted outcome reports for coronary artery
bypass graft surgeries, and to annually publish a new
risk-adjusted outcome report for all percutaneous cardiac
interventions and transcatheter valve procedures performed in
California. SB 830 was heard in this committee on April 24 and
passed out with a 9-0 vote.
5.Prior legislation. SB 357 (Correa), Chapter 202, Statutes of
2013, extended the January 1, 2014, sunset date for the PCI
Pilot Program to January 1, 2015, and required the final
report by the PCI Pilot Program oversight committee to be
completed by November 30, 2013, rather than at the conclusion
of the pilot program.
SB 891 (Correa), Chapter 295, Statutes of 2008, enacted the PCI
Pilot Program.
6.Support. The California Hospital Association (CHA) states in
support that this bill will allow CDPH to certify general
acute care hospitals, which meet the requirements of this
bill, to perform scheduled, elective PCI angioplasty and stent
placement for patients. CHA notes that the results of the
pilot study found that the six California hospitals
participating in the pilot program demonstrated similar safety
and efficacy results for elective and non-elective PCIs when
compared to hospitals with onsite surgery. The Los Alamitos
Medical Center also supports this bill, stating that it was
one of the pilot participants, and that it successfully
partnered with CDPH to generate clinical and economic data
that positions California to move forward with a permanent
SB 906 | Page
7
program, resulting in better outcomes for these procedures
along with enhanced patient safety.
SUPPORT AND OPPOSITION :
Support: American College of Cardiology - California Chapter
California Hospital Association
Los Alamitos Medical Center
Oppose: None received.
-- END --